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Table 6 Main themes discussed by stakeholders in open-ended questions

From: Comparison of two data collection processes in clinical studies: electronic and paper case report forms



About redundancy of data “It doesn’t matter whether it’s on paper or electronic, as long as data are entered only once."

That some promoters want them to complete a pCRF first as source document and then to re-enter all the data in the eCRF.

About software design companies “By trying to make money, firms that sell this type of CRF software developed templates that do not fit well with the variability of studies and data.”


To have their needs taken into account "eCRFs are developed by those who use data but never by those who enter the data and who have, in the present context, less and less availability.“

Working with transportable computers “The graphic tablet, an eCRF transportable to the bedside, is the solution for future. It’s already used in anesthesia with great success.“



CTAs needed on site: “Whatever the collection method, investigators don’t have the time …”

eCRF storage: CRFs still needs to be kept on paper, as source data and to be signed …


Complaints about CleanWEB consistency management

“Only simple checks can be defined in CleanWEB; more complicated ones must be programmed in SAS after database export.”

Moreover, “the computer code managing the automatic controls should be accessible and easily understood."

“The database structure isn’t known when designing eCRFs for CleanWEB, yet it is the first thing that must be established. And it’s currently impossible to have a structure that complies with CDISC."

  1. Answers from investigators, clinical research associates and data managers.
  2. CRA: clinical research associate, DM: data manager.